Identity
- Trade Name
- thermosept RKF EUDAMED
- Device Name
- thermosept RKF EUDAMED
- Model / Reference
- 146304 EUDAMED146309 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04032651463046 EUDAMED04032651463091 EUDAMED
- Basic UDI-DI
- 4032651BSC00000060AC EUDAMED
- EMDN Code
- D0899 DETERGENTS FOR MEDICAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
thermosept RKF by Schülke & Mayr GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4032651BSC00000060AC | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Schülke & Mayr GmbH
- EUDAMED SRN
- DE-MF-000005701
Sources (2)
- EUDAMED 8a655294-9de7-44e5-98a5-95c5718282f9 61 fields · synced Oct 6, 2026
- EUDAMED fb46660e-03f9-42b5-b8bc-d86aaafd32e8 61 fields · synced May 17, 2026